BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M¿ CUROS¿ DISINFECTING CAP FOR NEEDLELESS CONNECTORS

    MDR report key: 8577760 · Received May 3, 2019

    Report

    Report Number
    2110898-2019-00072
    Event Type
    Malfunction
    Date Received
    May 3, 2019
    Report Date
    May 3, 2019
    Manufacturer
    3M HEALTH CARE
    Product Code
    LKB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER REPORTED THAT A CUROS¿ DISINFECTING CAP WAS ATTACHED DIRECTLY TO A HICKMAN LINE AND MW 2110898-2019-00071 WAS SUBMITTED FOR THAT REPORT. THE CUSTOMER REPORTED DURING THEIR INVESTIGATION OF THAT REPORT, IT WAS FOUND THAT THIS OCCURRED, AN UNSPECIFIED NUMBER OF TIMES, AT OTHER HOSPITALS WITHIN THEIR NETWORK. NO INDIVIDUAL INFORMATION WAS PROVIDED REGARDING THE ADDITIONAL REPORTS. THE CUSTOMER REPORTED RE-EDUCATION OCCURRED AT EACH HOSPITAL. MW 2110898-2019-00072 WAS SUBMITTED FOR THIS ADDITIONAL REPORT. BOTH THE PRODUCT PACKAGING AND THE INSTRUCTIONS FOR USE (IFU) FOR 3M¿ CUROS¿ DISINFECTING CAP FOR NEEDLELESS CONNECTORS INSTRUCT THAT THE PRODUCT IS ONLY TO BE USED ON NEEDLELESS CONNECTORS. PRIMARY PACKAGING: IN MULTIPLE LOCATIONS ON THE PRIMARY PACKAGE, THE PRODUCT NAME AND DESCRIPTOR INDICATES THE PRODUCT IS TO BE USED WITH NEEDLESS CONNECTORS. THE GENERIC DESCRIPTOR "DISINFECTING CAP FOR NEEDLESS CONNECTORS" IS TRANSLATED IN 27 LANGUAGES. THE PACKAGING ALSO INCLUDES THE "WARNING, SEE IFU" SYMBOL, WHICH SHOULD DIRECT THE USER TO THE IFU FOR FULL WARNING INFORMATION. IFU: INFORMATION REGARDING THE USE WITH NEEDLESS CONNECTORS CAN BE FOUND IN MULTIPLE LOCATIONS WITHIN THE IFU, IN BOLD LETTERING. PRODUCT NAME AND GENERIC DESCRIPTOR 3M¿ CUROS¿ DISINFECTING CAP FOR NEEDLELESS CONNECTORS (TRANSLATED INTO 27 LANGUAGES). INTENDED USE: THE CUROS¿ DISINFECTING CAP IS INTENDED FOR USE ON NEEDLELESS CONNECTORS ONLY. WARNING: TO AVOID POTENTIAL FOR INJURY - USE ONLY ON NEEDLELESS CONNECTORS. PRODUCT PACKAGING INCLUDES GRAPHICS INSTRUCTING CUSTOMERS TO APPLY THE CUROS CAP ONLY TO NEEDLELESS CONNECTORS AND NOT TO APPLY THE CUROS CAP DIRECTLY TO A CATHETER HUB. IN ADDITION, 3M PROVIDES TRAINING MATERIALS (INCLUDING GRAPHICS) INSTRUCTING CUSTOMERS TO APPLY THE CUROS CAP ONLY TO NEEDLELESS CONNECTORS AND NOT TO APPLY THE CUROS CAP DIRECTLY TO A CATHETER HUB.

    Description of Event or Problem · 1

    3M EUROPE (EU) RECEIVED A REPORT FROM THE EU AUTHORITIES (MHRA). A CUSTOMER NOTED IN A REPORT THAT THERE WAS AN UNSPECIFIED NUMBER OF INCIDENTS WHERE A CFF1-270R 3M¿ CUROS¿ DISINFECTING CAP FOR NEEDLELESS CONNECTOR WAS ATTACHED DIRECTLY TO A HICKMAN LINE AT DIFFERENT HOSPITALS WITHIN THEIR NETWORK. THE CUSTOMER REPORTED RE-EDUCATION WAS PROVIDED. NO SPECIFIC INFORMATION WAS PROVIDED RELATED TO THE INDIVIDUAL INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372283 3M¿ CUROS¿ DISINFECTING CAP FOR NEEDLELESS CONNECTORS CUROS DISINFECTING CAP FOR NEEDLELESS CONNECTORS LKB 3M HEALTH CARE N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1